Singh Rishi P, Kaiser Peter K
Cole Eye Institute, Cleveland Clinic Foundation, USA.
Indian J Ophthalmol. 2007 Nov-Dec;55(6):421-5. doi: 10.4103/0301-4738.36475.
Age-related macular degeneration (AMD) is one of the most common causes of severe vision loss in the western world. Both animal and human studies have established that vascular endothelial growth factor (VEGF) plays an important role in the pathogenesis of this process. Ranibizumab (Lucentis(TM) Genentech, South San Francisco, CA) is a monoclonal antibody fragment (Fab) directed toward all isoforms of VEGF-A that was specifically designed to target wet AMD. The human antibody fragment is produced by an E. coli expression system and has a molecular weight of 48kD allowing for excellent retinal penetration. The most common ocular complaints of patients receiving ranibizumab injections in randomized clinical trials were transient conjunctival hemorrhage, vitreous floaters, intraocular inflammation, increased intraocular pressure and eye pain. The rates of serious adverse events such as retinal detachment, cataract and endophthalmitis were similar to those that have been reported with other intravitreal injections and patients should always be treated under strict aseptic conditions to reduce this risk. There were no significant non-ocular events found during any study so far and the risk of thromboembolic events was less than 4% and not different than sham. The MARINA, ANCHOR and PIER studies validated the safety and efficacy of ranibizumab amongst a large population with different choroidal neovascular membrane lesion types against sham or standard of care treatment. These studies recommended monthly intravitreal ranibizumab for patients. However, the PIER study reported that an alternative dosing of every three months is acceptable but less effective than monthly injections.
年龄相关性黄斑变性（AMD）是西方世界严重视力丧失的最常见原因之一。动物和人体研究均已证实，血管内皮生长因子（VEGF）在这一过程的发病机制中起重要作用。雷珠单抗（Lucentis™，基因泰克公司，加利福尼亚州南旧金山）是一种针对VEGF-A所有亚型的单克隆抗体片段（Fab），专门设计用于治疗湿性AMD。该人源抗体片段由大肠杆菌表达系统产生，分子量为48kD，具有出色的视网膜穿透性。在随机临床试验中，接受雷珠单抗注射的患者最常见的眼部不适为短暂性结膜出血、玻璃体飞蚊症、眼内炎症、眼压升高和眼痛。视网膜脱离、白内障和眼内炎等严重不良事件的发生率与其他玻璃体内注射报告的发生率相似，患者应始终在严格的无菌条件下接受治疗以降低这种风险。到目前为止，在任何研究中均未发现明显的非眼部事件，血栓栓塞事件的风险低于4%，与假注射无差异。MARINA、ANCHOR和PIER研究验证了雷珠单抗在大量不同脉络膜新生血管膜病变类型人群中相对于假注射或标准治疗的安全性和有效性。这些研究建议患者每月进行玻璃体内注射雷珠单抗。然而，PIER研究报告称，每三个月一次的替代给药方案是可以接受的，但效果不如每月注射。
